Pink Sheet Interviews Howard Sklamberg on FDA Inspectorate Reorganization

Howard Sklamberg, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the recent Pink Sheet article, “U.S. FDA Plans Move Back To More Generalist Inspectorate,” analyzing the FDA’s plan to merge its medical product and clinical research inspectorates into a “Simple Reform” initiative.

Howard noted that the previous program alignment specialized inspectors by commodity, allowing them to receive on-the-job training based on their area of oversight and, hopefully, improving the preapproval and prelicensure inspection process.

“If you’re doing a pre-licensing inspection for a complex cell and gene therapy, the manufacturing processes for those products are very complicated,” Howard said. “It requires a lot more training to be competent to do those kinds of inspections and you can only be at that cutting edge competency in so many things. There’s only so many hours in the day to get trained enough to be at the level.”

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